NCT03093467: ASCENSO

Effectiveness of an Internet-based Intervention for the Treatment of Depression

Completed NA Last updated 8 April 2021

What this trial tests

NA trial testing ASCENSO in Depression in 167 participants. Completed in 13 November 2019.

Timeline

29 May 2017

Primary endpoint
13 November 2019

13 November 2019

Quick facts

Lead sponsor	Instituto Milenio para Investigación en Depresión y Personalidad
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	167
Start date	29 May 2017
Primary completion	13 November 2019
Estimated completion	13 November 2019
Sites	1 location across Chile

Drugs / interventions tested

• ASCENSO
• Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers. — full drug profile →
• Psychotherapy

Conditions studied

• Depression — all drugs for Depression →

Sponsor

Instituto Milenio para Investigación en Depresión y Personalidad — full company profile →

Who can join

Adults 18 to 65, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Depression is a highly prevalent disorder in Chile, generating important personal and social costs. This study aims to evaluate the effectiveness of the internet-based program ASCENSO as an adjunct intervention for the treatment of depression. ASCENSO provides information to promote patients' self-care, it monitors reported depression symptoms providing automatized feedback and provides the possibility of booking a counseling session via chat or by phone. To evaluate the effectiveness of ASCENSO, an open, evaluator-blind, prospective, parallel-group (one intervention group and one active control group) randomized controlled trial will be implemented in one mental health center in Santiago of Chile. The sample will be composed of adults initiating treatment for depression, and who have internet access. Participants will be randomly assigned to one of the two study arms. Randomization will be stratified by the number of patients´ previous episodes (dichotomized into none, 1 or more), following a permuted block randomization procedure. Patients in the experimental group (n=100) will receive the usual treatment plus access to the ASCENSO program. The control group (n=100) will only receive the usual treatment. At recruitment, months 6 and 9, patients' self-reported depression symptoms and quality of life will be assessed. Additionally, adherence to treatment in terms of patients' attendance to medical controls and psychotherapy sessions will be registered for both research groups.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. An Adjunctive Internet-Based Intervention to Enhance Treatment for Depression in Adults: Randomized Controlled Trial.
   Pérez JC, Fernández O, Cáceres C, Carrasco ÁE, et al · · 2021 · cited 14× · PMID 34927594 · DOI 10.2196/26814